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君实生物(688180.SH):JS007注射液药物临床试验申请获受理
格隆汇 04-07 16:59

格隆汇4月7日丨君实生物(688180.SH)公布,近日,公司收到国家药品监督管理局核准签发的《受理通知书》,JS007注射液(项目代号“JS007”)的临床试验申请获得受理。

JS007是公司自主研发的重组人源化抗CTLA-4单克隆抗体注射液,主要用于晚期恶性肿瘤的治疗。细胞毒性T淋巴细胞抗原-4(Cytotoxic T lymphocyte-associated antigen-4,CTLA-4)是T细胞表面调节免疫应答的一个重要受体。JS007可以特异性地与CTLA-4结合并有效阻断CTLA-4与其配体B7(CD80或CD86)的相互作用,从而活化T淋巴细胞,抑制肿瘤生长。目前同靶点国外已上市药物ipilimumab作为首个免疫检查点抑制剂在黑色素瘤、淋巴瘤、肾细胞癌、尿路上皮癌、卵巢癌和非小细胞肺癌等多个瘤种中被证实具有显著的抑癌作用,并获批治疗晚期黑色素瘤。临床前研究资料显示,JS007与同靶点但具有不同序列的ipilimumab相比具有相似的安全性,但有更好的药效。

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